SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT01245556

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Phase 1 Study of a RAF Inhibitor (BMS-908662) Administered in Combination With Immunotherapy (Ipilimumab) in Subjects With Unresectable Stage III or Stage IV Melanoma

The purpose of the study is to identify a safe and tolerable dose of BMS-908662 in combination with ipilimumab; and then to evaluate the anti-tumor response to BMS-908662 when administered in combination with ipilimumab.

NCT01245556 Melanoma
MeSH: Melanoma
HPO: Cutaneous melanoma Melanoma

4 Interventions

Name: BMS-908662

Description: Capsules, Oral, escalating doses starting at 25 mg, Q 12 h daily, Continuously

Type: Drug

BMS-908662 or Ipilimumab (A)

Name: BMS-908662

Description: Capsules, Oral, escalating doses starting at 25 mg Q 12 h daily for 3 weeks with 3 weeks interval for 4 cycles, then Q12 h daily for 3 weeks every 12 weeks, Continuously

Type: Drug

BMS-908662 or Ipilimumab (B)

Name: Ipilimumab

Description: Vial, IV, escalating doses starting at 3 mg/kg, Once every 3 weeks for 6 weeks, then once every 12 weeks, Continuously

Type: Drug

BMS-908662 or Ipilimumab (A)

Name: Ipilimumab

Description: Vial, IV, escalating doses starting at 3 mg/kg, Once every 6 weeks for 4 cycles, then once every 12 weeks, Continuously

Type: Drug

BMS-908662 or Ipilimumab (B)


Primary Outcomes

Measure: Toxicity will be evaluated according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3

Time: Assessments approximately every 3 weeks throughout the duration of the trial

Secondary Outcomes

Measure: Efficacy as determined by estimates of objective response rates and response duration

Time: Efficacy measured every 6 weeks until week 48, then every 12 weeks

Measure: PK for BMS-908662 as determined by minimum and maximum observed concentrations, time of maximum observed concentration, area under the concentration curve for one dosing interval and the accumulation index

Time: PK measured during first 4 weeks on study

Measure: PD will be assessed by evaluating markers of RAS/RAF pathway activity

Time: PD assessed during the first 4 weeks on study

Purpose: Treatment

Allocation: Non-Randomized

Parallel Assignment


There is one SNP

SNPs


1 V600E

Inclusion: - Male and female subjects ≥ 18 years of age with a histologic or cytologic diagnosis of Stage III or Stage IV (unresectable) melanoma - Enrollment to cohort expansion will be limited to only those subjects whose tumors demonstrate the B-Raf V600E mutation - ECOG ≤ 1 - Adequate organ & marrow function Exclusion: - Uncontrolled or significant cardiovascular disease - Cohort expansion: Prior therapy with a RAF inhibitor Inclusion: - Male and female subjects ≥ 18 years of age with a histologic or cytologic diagnosis of Stage III or Stage IV (unresectable) melanoma - Enrollment to cohort expansion will be limited to only those subjects whose tumors demonstrate the B-Raf V600E mutation - ECOG ≤ 1 - Adequate organ & marrow function Exclusion: - Uncontrolled or significant cardiovascular disease - Cohort expansion: Prior therapy with a RAF inhibitor Melanoma Melanoma null --- V600E ---

Inclusion: - Male and female subjects ≥ 18 years of age with a histologic or cytologic diagnosis of Stage III or Stage IV (unresectable) melanoma - Enrollment to cohort expansion will be limited to only those subjects whose tumors demonstrate the B-Raf V600E mutation - ECOG ≤ 1 - Adequate organ & marrow function Exclusion: - Uncontrolled or significant cardiovascular disease - Cohort expansion: Prior therapy with a RAF inhibitor Inclusion: - Male and female subjects ≥ 18 years of age with a histologic or cytologic diagnosis of Stage III or Stage IV (unresectable) melanoma - Enrollment to cohort expansion will be limited to only those subjects whose tumors demonstrate the B-Raf V600E mutation - ECOG ≤ 1 - Adequate organ & marrow function Exclusion: - Uncontrolled or significant cardiovascular disease - Cohort expansion: Prior therapy with a RAF inhibitor Melanoma Melanoma null --- V600E --- --- V600E ---



HPO Nodes


HPO:
Cutaneous melanoma
Genes 11
BRAF HRAS XPC CDKN2A POLH ERCC3 BAP1 CXCR4 MC1R NRAS WRN
Melanoma
Genes 64
RAD51 RAD51C TYR RAD51D CDKN2A KRAS CDKN2B RAF1 CDKN2D MRE11 CYSLTR2 ERCC2 KLLN PTPN11 ERCC3 BRIP1 ERCC4 ERCC5 ERCC6 SF3B1 NRAS MGMT BRCA1 MBTPS2 BRAF ACD BRCA2 PIK3CA CXCR4 CTSC POLH POT1 MC1R MITF WRN CHEK2 HRAS BARD1 NBN AKT1 SLC45A2 GNA11 TRPV3 XPA OCA2 XPC GNAQ PTEN MDM2 TERT DDB2 RNF43 PALLD PALB2 TERF2IP SEC23B TP53 SDHB SDHC SDHD SMAD4 BAP1 CDK4 RAD50